Japanese Encephalitis, Measles, Mumps, Rubella
Conditions
Keywords
Japanese Encephalitis, Japanese encephalitis chimeric virus vaccine, Measles, Mumps, Rubella
Brief summary
This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months. Primary objective: * To demonstrate the non-inferiority of the antibody responses in terms of seroconversion of the concomitant administration of JE-CV and MMR compared to the antibody responses after the single administration of JE-CV and MMR vaccine. Secondary objectives: * To describe the immune response to JE CV and MMR before and after one dose of JE CV and MMR vaccine, respectively. * To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a 6-week interval and the safety of the concomitant administration of JE-CV and MMR vaccine in all subjects up to 6 months after last vaccination.
Detailed description
All participants will receive Japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.
Interventions
BIOLOGICALJapanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
0.5 mL each; Subcutaneous (SC)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 12 to 18 months on the day of inclusion . * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg. * Subject in good health based on medical history and physical examination. * Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by an independent witness if the parents or legally acceptable representative cannot read. * Subject and parent/legally acceptable representative or delegate able to attend all scheduled visits and comply with all trial procedures.
Exclusion criteria
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the present trial period. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines. * Planned receipt of any vaccine up to the 6 weeks following the last trial vaccination except for pandemic influenza vaccine. In the event of a local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial. * Previous vaccination against measles, measles-mumps-rubella (MMR), or flavivirus disease, including Japanese encephalitis (JE). * Receipt of blood in the past 6 months that might interfere with the assessment of the immune response * Receipt of intravenous injection of plasma, platelet product, or high dose of intravenous immunoglobulin in the past 11 months * Receipt of intramuscular treatment of immunoglobulin or Hepatitis B immunoglobulin in the past 3 months * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. * Known history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C seropositivity. * History of measles, mumps, rubella, or flavivirus infection confirmed either clinically, serologically, or microbiologically. * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances . * Known systemic hypersensitivity to gelatin, eggs, or anaphylactic/anaphylactoid reaction to neomycin. * Known history of thrombocytopenia. * Administration of any anti-viral within 2 months preceding first vaccination and up to the 6 weeks following the last trial vaccination. * History of central nervous system disorder or disease, including seizures and febrile seizures. * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Day 0 (pre-vaccination) and Day 42 post-vaccination | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Pre-vaccination and Day 42 post-vaccination | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/m |
| Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Pre-vaccination and up to Month 12 post-vaccination | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is \<10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is \<10 IU/m |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Day 0 up to Day14 post-vaccination | Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - \>39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \>3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable. |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Day 0 up to Day 14 post-vaccination | Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - \>39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \>3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable. |
| Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Pre-vaccination and Day 42 post-vaccination | JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Day 0 (pre-vaccination) | Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus \< 10 (l/dil) and antibodies against the 4 dengue virus serotypes \< 10 (l/dil). |
Countries
Taiwan
Participant flow
Recruitment details
Study participants were enrolled from 14 August 2010 through 28 July 2011 at 5 clinic centers in Taiwan.
Pre-assignment details
A total of 550 participants who met all of the inclusion and none of the exclusion criteria were randomized, 542 were vaccinated and reported.
Participants by arm
| Arm | Count |
|---|---|
| JE CV + MMR (Group 1) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42 | 102 |
| MMR + JE CV (Group 2) Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42 | 219 |
| JE CV/MMR (Group 3) Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0 | 221 |
| Total | 542 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Not vaccinated | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 24 | 0 |
Baseline characteristics
| Characteristic | MMR + JE CV (Group 2) | JE CV/MMR (Group 3) | JE CV + MMR (Group 1) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 219 Participants | 221 Participants | 102 Participants | 542 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.0 Months STANDARD_DEVIATION 1.08 | 13.1 Months STANDARD_DEVIATION 1.19 | 13.1 Months STANDARD_DEVIATION 1.12 | 13.1 Months STANDARD_DEVIATION 1.13 |
| Region of Enrollment Taiwan | 219 Participants | 221 Participants | 102 Participants | 542 Participants |
| Sex: Female, Male Female | 110 Participants | 109 Participants | 46 Participants | 265 Participants |
| Sex: Female, Male Male | 109 Participants | 112 Participants | 56 Participants | 277 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 102 | 80 / 219 | 79 / 220 |
| serious Total, serious adverse events | 10 / 102 | 21 / 219 | 13 / 220 |
Outcome results
Primary
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml.
Time frame: Day 0 (pre-vaccination) and Day 42 post-vaccination
Population: Seroconversion was assessed in the Per Protocol Analysis Set with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | JE-CV (N = 95, 0, 194) | 97.9 Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Measles (N = 0, 170, 193) | NA Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Mumps (N = 0, 173, 194) | NA Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Rubella (N = 0, 154, 178) | NA Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Rubella (N = 0, 154, 178) | 99.4 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | JE-CV (N = 95, 0, 194) | NA Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Mumps (N = 0, 173, 194) | 98.8 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Measles (N = 0, 170, 193) | 97.6 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Rubella (N = 0, 154, 178) | 99.4 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Measles (N = 0, 170, 193) | 100 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | Mumps (N = 0, 173, 194) | 99.5 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination | JE-CV (N = 95, 0, 194) | 96.9 Percentage of Participants |
Secondary
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).
Time frame: Pre-vaccination and Day 42 post-vaccination
Population: Geometric mean titers were assessed in the Per Protocol Analysis Set population with evaluable data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| JE-CV + MMR (Group 1) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV pre-vaccination (N = 95, 158, 194) | 5.00 Titers |
| JE-CV + MMR (Group 1) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV post-vaccination (N = 95, 158, 194) | 510 Titers |
| JE-CV + MMR (Group 1) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles pre-vaccination (N = 94, 176, 196) | 34.3 Titers |
| JE-CV + MMR (Group 1) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles post-vaccination (N = 94, 176, 197) | 1835 Titers |
| JE-CV + MMR (Group 1) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps pre-vaccination (N = 94, 176, 196) | 2.59 Titers |
| JE-CV + MMR (Group 1) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Post-vaccination (N = 94, 176, 197) | 81.1 Titers |
| JE-CV + MMR (Group 1) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella pre-vaccination (N = 94, 176, 196) | 3.90 Titers |
| JE-CV + MMR (Group 1) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella post-vaccination (N = 94, 176, 197) | 78.0 Titers |
| MMR + JE-CV (Group 2) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles pre-vaccination (N = 94, 176, 196) | 33.4 Titers |
| MMR + JE-CV (Group 2) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella pre-vaccination (N = 94, 176, 196) | 3.97 Titers |
| MMR + JE-CV (Group 2) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles post-vaccination (N = 94, 176, 197) | 1723 Titers |
| MMR + JE-CV (Group 2) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps pre-vaccination (N = 94, 176, 196) | 2.63 Titers |
| MMR + JE-CV (Group 2) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Post-vaccination (N = 94, 176, 197) | 87.5 Titers |
| MMR + JE-CV (Group 2) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV pre-vaccination (N = 95, 158, 194) | 5.00 Titers |
| MMR + JE-CV (Group 2) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV post-vaccination (N = 95, 158, 194) | 581 Titers |
| MMR + JE-CV (Group 2) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella post-vaccination (N = 94, 176, 197) | 81.4 Titers |
| JE-CV/MMR (Group 3) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles pre-vaccination (N = 94, 176, 196) | 33.4 Titers |
| JE-CV/MMR (Group 3) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV post-vaccination (N = 95, 158, 194) | 332 Titers |
| JE-CV/MMR (Group 3) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV pre-vaccination (N = 95, 158, 194) | 5.00 Titers |
| JE-CV/MMR (Group 3) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles post-vaccination (N = 94, 176, 197) | 1924 Titers |
| JE-CV/MMR (Group 3) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella pre-vaccination (N = 94, 176, 196) | 3.60 Titers |
| JE-CV/MMR (Group 3) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Post-vaccination (N = 94, 176, 197) | 89.2 Titers |
| JE-CV/MMR (Group 3) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps pre-vaccination (N = 94, 176, 196) | 2.55 Titers |
| JE-CV/MMR (Group 3) | Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella post-vaccination (N = 94, 176, 197) | 69.6 Titers |
Secondary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - \>39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \>3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.
Time frame: Day 0 up to Day14 post-vaccination
Population: Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Injection site Erythema (N = 102, 195, 219) | 11 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Injection site Pain (N = 102, 195, 219) | 18 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Pain (N = 102, 195, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Erythema (N = 102, 195, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Injection site Swelling (N = 102, 195, 219) | 2 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Swelling (N = 102, 195, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Fever (N = 102, 195, 219) | 17 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Fever (N = 102, 195, 219) | 1 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Vomiting (N = 102, 195, 219) | 15 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Vomiting (N = 102, 195, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Crying Abnormal (N = 102, 195, 219) | 24 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Crying Abnormal (N = 102, 195, 219) | 2 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Drowsiness (N = 102, 195, 219) | 26 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Drowsiness (N = 102, 195, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Appetite Lost (N = 102, 195, 219) | 25 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Appetite Lost (N = 102, 195, 219) | 3 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Irritability (N = 102, 195, 219) | 28 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Irritability (N = 102, 195, 219) | 4 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Irritability (N = 102, 195, 219) | 0 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Injection site Erythema (N = 102, 195, 219) | 21 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Drowsiness (N = 102, 195, 219) | 45 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Injection site Pain (N = 102, 195, 219) | 30 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Vomiting (N = 102, 195, 219) | 3 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Appetite Lost (N = 102, 195, 219) | 46 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Pain (N = 102, 195, 219) | 0 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Appetite Lost (N = 102, 195, 219) | 5 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Crying Abnormal (N = 102, 195, 219) | 56 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Irritability (N = 102, 195, 219) | 39 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Erythema (N = 102, 195, 219) | 0 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Vomiting (N = 102, 195, 219) | 21 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Drowsiness (N = 102, 195, 219) | 3 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Injection site Swelling (N = 102, 195, 219) | 11 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Fever (N = 102, 195, 219) | 1 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Crying Abnormal (N = 102, 195, 219) | 4 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Swelling (N = 102, 195, 219) | 0 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Fever (N = 102, 195, 219) | 35 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Swelling (N = 102, 195, 219) | 0 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Fever (N = 102, 195, 219) | 53 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Fever (N = 102, 195, 219) | 1 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Appetite Lost (N = 102, 195, 219) | 78 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Vomiting (N = 102, 195, 219) | 39 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Irritability (N = 102, 195, 219) | 2 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Vomiting (N = 102, 195, 219) | 0 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Crying Abnormal (N = 102, 195, 219) | 79 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Appetite Lost (N = 102, 195, 219) | 6 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Crying Abnormal (N = 102, 195, 219) | 5 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Injection site Pain (N = 102, 195, 219) | 35 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Drowsiness (N = 102, 195, 219) | 67 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Pain (N = 102, 195, 219) | 0 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Injection site Erythema (N = 102, 195, 219) | 24 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Erythema (N = 102, 195, 219) | 0 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Injection site Swelling (N = 102, 195, 219) | 3 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Grade 3 Drowsiness (N = 102, 195, 219) | 2 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine | Solicited Irritability (N = 102, 195, 219) | 72 Participants |
Secondary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - \>39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \>3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.
Time frame: Day 0 up to Day 14 post-vaccination
Population: Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Injection site Swelling (N = 101, 211, 219) | 3 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Pain (N = 101, 211, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Injection site Erythema (N = 101, 211, 219) | 7 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Erythema (N = 101, 211, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Injection site Pain (N = 101, 211, 219) | 16 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Swelling (N = 101, 211, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Fever (N = 101, 211, 219) | 21 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Fever (N = 101, 211, 219) | 1 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Vomiting (N = 101, 210, 219) | 12 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Vomiting (N = 101, 210, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Crying Abnormal (N = 101, 210, 219) | 30 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Crying Abnormal (N = 101, 210, 219) | 4 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Drowsiness (N = 101, 210, 219) | 26 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Drowsiness (N = 101, 210, 219) | 1 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Appetite Lost (N = 101, 210, 219) | 29 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Appetite Lost (N = 101, 210, 219) | 0 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Irritability (N = 101, 210, 219) | 26 Participants |
| JE-CV + MMR (Group 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Irritability (N = 101, 210, 219) | 4 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Irritability (N = 101, 210, 219) | 3 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Injection site Pain (N = 101, 211, 219) | 32 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Vomiting (N = 101, 210, 219) | 2 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Drowsiness (N = 101, 210, 219) | 68 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Pain (N = 101, 211, 219) | 0 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Appetite Lost (N = 101, 210, 219) | 80 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Appetite Lost (N = 101, 210, 219) | 10 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Injection site Erythema (N = 101, 211, 219) | 22 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Crying Abnormal (N = 101, 210, 219) | 73 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Irritability (N = 101, 210, 219) | 64 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Erythema (N = 101, 211, 219) | 0 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Vomiting (N = 101, 210, 219) | 32 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Drowsiness (N = 101, 210, 219) | 4 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Injection site Swelling (N = 101, 211, 219) | 7 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Fever (N = 101, 211, 219) | 4 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Crying Abnormal (N = 101, 210, 219) | 7 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Swelling (N = 101, 211, 219) | 0 Participants |
| MMR + JE-CV (Group 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Fever (N = 101, 211, 219) | 48 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Swelling (N = 101, 211, 219) | 0 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Fever (N = 101, 211, 219) | 53 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Fever (N = 101, 211, 219) | 1 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Appetite Lost (N = 101, 210, 219) | 78 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Vomiting (N = 101, 210, 219) | 39 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Irritability (N = 101, 210, 219) | 2 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Vomiting (N = 101, 210, 219) | 0 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Crying Abnormal (N = 101, 210, 219) | 79 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Appetite Lost (N = 101, 210, 219) | 6 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Crying Abnormal (N = 101, 210, 219) | 5 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Injection site Pain (N = 101, 211, 219) | 36 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Pain (N = 101, 211, 219) | 0 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Drowsiness (N = 101, 210, 219) | 67 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Injection site Erythema (N = 101, 211, 219) | 22 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Erythema (N = 101, 211, 219) | 0 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Injection site Swelling (N = 101, 211, 219) | 4 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Grade 3 Drowsiness (N = 101, 210, 219) | 2 Participants |
| JE-CV/MMR (Group 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine | Solicited Irritability (N = 101, 210, 219) | 72 Participants |
Secondary
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is \<10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is \<10 IU/m
Time frame: Pre-vaccination and up to Month 12 post-vaccination
Population: Seroprotection to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated and who performed all protocol defined activities the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV Pre-vaccination (N=102, 197, 221) | 2 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV 6 months Post-vaccination (N=96, 191, 217) | 92 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV 12 months Post-vaccination (N=89, 164, 193) | 86 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles Pre-vaccination (N = 101, 217, 219) | 4 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles 6 months Post-vaccination (N=96, 191, 217) | 93 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles 12 months Post-vaccination (N=89, 164, 193 | 87 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Pre-vaccination (N=101, 217, 219) | 1 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps 6 months Post-vaccination (N=96, 191, 217) | 90 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps 12 months Post-vaccination (N=89, 164, 193) | 82 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella Pre-vaccination (N=101, 217, 219) | 10 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella 6 months Post-vaccination (N=96, 191, 217) | 95 Participants |
| JE-CV + MMR (Group 1) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella 12 months Post-vaccination (N=89, 164, 193 | 89 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella 12 months Post-vaccination (N=89, 164, 193 | 164 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV Pre-vaccination (N=102, 197, 221) | 10 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Pre-vaccination (N=101, 217, 219) | 2 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps 12 months Post-vaccination (N=89, 164, 193) | 153 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV 6 months Post-vaccination (N=96, 191, 217) | 190 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles 12 months Post-vaccination (N=89, 164, 193 | 163 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella 6 months Post-vaccination (N=96, 191, 217) | 191 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV 12 months Post-vaccination (N=89, 164, 193) | 162 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps 6 months Post-vaccination (N=96, 191, 217) | 180 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles 6 months Post-vaccination (N=96, 191, 217) | 189 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles Pre-vaccination (N = 101, 217, 219) | 8 Participants |
| MMR + JE-CV (Group 2) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella Pre-vaccination (N=101, 217, 219) | 23 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles Pre-vaccination (N = 101, 217, 219) | 2 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles 6 months Post-vaccination (N=96, 191, 217) | 216 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella Pre-vaccination (N=101, 217, 219) | 19 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles 12 months Post-vaccination (N=89, 164, 193 | 192 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Pre-vaccination (N=101, 217, 219) | 2 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps 6 months Post-vaccination (N=96, 191, 217) | 208 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella 6 months Post-vaccination (N=96, 191, 217) | 217 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV Pre-vaccination (N=102, 197, 221) | 4 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV 6 months Post-vaccination (N=96, 191, 217) | 203 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps 12 months Post-vaccination (N=89, 164, 193) | 176 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV 12 months Post-vaccination (N=89, 164, 193) | 171 Participants |
| JE-CV/MMR (Group 3) | Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella 12 months Post-vaccination (N=89, 164, 193 | 192 Participants |
Secondary
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/m
Time frame: Pre-vaccination and Day 42 post-vaccination
Population: Seroconversion to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated, who performed all protocol defined activities and has evaluable data (Per-protocol Analysis Set).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV Pre-vaccination (N = 95, 158, 194) | 0.0 Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV Post-vaccination (N = 95, 158, 194) | 97.9 Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles Pre-vaccination (N = 94, 176, 196) | 4.3 Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles Post-vaccination (N = 94, 176, 197) | 97.9 Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Pre-vaccination (N = 94, 176, 196) | 1.1 Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Post-vaccination (N = 94, 176, 197) | 100.0 Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella Pre-vaccination (N = 94, 176, 196) | 9.6 Percentage of Participants |
| JE-CV + MMR (Group 1) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella Post-vaccination (N = 94, 176, 197) | 100.0 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles Pre-vaccination (N = 94, 176, 196) | 2.8 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella Pre-vaccination (N = 94, 176, 196) | 11.9 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles Post-vaccination (N = 94, 176, 197) | 97.7 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Pre-vaccination (N = 94, 176, 196) | 1.1 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Post-vaccination (N = 94, 176, 197) | 98.9 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV Pre-vaccination (N = 95, 158, 194) | 0.0 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV Post-vaccination (N = 95, 158, 194) | 100.0 Percentage of Participants |
| MMR + JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella Post-vaccination (N = 94, 176, 197) | 99.4 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles Pre-vaccination (N = 94, 176, 196) | 1.0 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV Post-vaccination (N = 95, 158, 194) | 96.9 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV Pre-vaccination (N = 95, 158, 194) | 0.0 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Measles Post-vaccination (N = 94, 176, 197) | 100.0 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella Pre-vaccination (N = 94, 176, 196) | 8.7 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Post-vaccination (N = 94, 176, 197) | 99.5 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Mumps Pre-vaccination (N = 94, 176, 196) | 0.5 Percentage of Participants |
| JE-CV/MMR (Group 3) | Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Rubella Post-vaccination (N = 94, 176, 197) | 99.5 Percentage of Participants |
Other Pre-specified
Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus \< 10 (l/dil) and antibodies against the 4 dengue virus serotypes \< 10 (l/dil).
Time frame: Day 0 (pre-vaccination)
Population: Serological status of Flavivirus infection was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV + MMR (Group 1) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV virus/dengue serotypes FV Positive | 2 Participants |
| JE-CV + MMR (Group 1) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE CV virus/dengue serotypes FV Negative | 100 Participants |
| JE-CV + MMR (Group 1) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE CV virus | 2 Participants |
| JE-CV + MMR (Group 1) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Any dengue serotype | 0 Participants |
| JE-CV + MMR (Group 1) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 1 | 0 Participants |
| JE-CV + MMR (Group 1) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 2 | 0 Participants |
| JE-CV + MMR (Group 1) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 3 | 0 Participants |
| JE-CV + MMR (Group 1) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 4 | 0 Participants |
| MMR + JE-CV (Group 2) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE CV virus | 10 Participants |
| MMR + JE-CV (Group 2) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 3 | 0 Participants |
| MMR + JE-CV (Group 2) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Any dengue serotype | 8 Participants |
| MMR + JE-CV (Group 2) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 1 | 7 Participants |
| MMR + JE-CV (Group 2) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 2 | 0 Participants |
| MMR + JE-CV (Group 2) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV virus/dengue serotypes FV Positive | 18 Participants |
| MMR + JE-CV (Group 2) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE CV virus/dengue serotypes FV Negative | 179 Participants |
| MMR + JE-CV (Group 2) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 4 | 3 Participants |
| JE-CV/MMR (Group 3) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE CV virus | 4 Participants |
| JE-CV/MMR (Group 3) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE CV virus/dengue serotypes FV Negative | 216 Participants |
| JE-CV/MMR (Group 3) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | JE-CV virus/dengue serotypes FV Positive | 5 Participants |
| JE-CV/MMR (Group 3) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Any dengue serotype | 1 Participants |
| JE-CV/MMR (Group 3) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 3 | 0 Participants |
| JE-CV/MMR (Group 3) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 2 | 0 Participants |
| JE-CV/MMR (Group 3) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 1 | 1 Participants |
| JE-CV/MMR (Group 3) | Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine | Dengue serotype 4 | 0 Participants |